Pfizer and Moderna's updated COVID boosters win FDA nods, with swift rollouts to follow

The public's wait for another round of COVID-19 vaccine boosters is finally coming to an end.

Wednesday morning, the FDA gave the all-clear to Omicron-targeted COVID-19 shots from Moderna and Pfizer-BioNTech. The pair of bivalent mRNA vaccines have scored emergency use authorizations as single-dose inoculations to be given at least two months after primary or initial booster vaccination, the regulator said in a release.

The updated boosters each house two messenger RNA (mRNA) components of the coronavirus—one of the original SARS-CoV-2 strain, and another one in common between the BA.4 and BA.5 lineages of the omicron variant.

Moderna’s re-tooled vaccine has been given the thumbs-up in adults ages 18 years and older, while Pfizer and BioNTech’s updated booster can be used in people ages 12 and up.

"As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants," FDA commissioner Robert Califf said in a statement.

The emergency nods likely set the shots up for a quick nationwide rollout around Labor Day.

A CDC endorsement is the last logistical hurdle standing between the shots and a wider public deployment. The public health agency is set to convene its outside advisory panel of vaccine experts this Thursday and Friday.

Hospitals, pharmacies and other vaccination sites could start administering the updated boosters after the CDC's endorsement.

Pfizer-BioNTech and Moderna have also telegraphed their readiness to ship doses shortly after the FDA’s authorization. The U.S. government recently locked up 66 million doses of Moderna’s updated vaccine, plus 105 million doses of Pfizer-BioNTech’s new shot for the upcoming fall campaign.

Around 109 million people in the U.S. have received their first booster dose, according to the CDC, with about 23 million having received a second.

Public health experts are hoping the re-vamped vaccines will improve the nation’s booster rate, which has stagnated in recent months, The Wall Street Journal reports.

Meanwhile, some critics have taken issue with the speed at which Pfizer and Moderna’s updated shots passed muster with regulators. A major point of contention has been whether the boosters should have been greenlit without data from human trials.

For its part, the FDA said it based the decisions on the "totality of available evidence," including the large body of data in the original COVID-19 shots, plus a clinical study in an earlier BA.1-targeted vaccine.

Pfizer recently said it would kick off human safety and effectiveness trials on its re-tooled shot by the end of August, while Moderna has one such phase 2/3 study underway.